Studies on Thyroid Nodules and Thyroid Cancer

Purpose:

Participants in this study will be patients diagnosed with or suspected to have a thyroid
nodule or thyroid cancer.
The main purpose of this study is to further understand the methods for the diagnosis and
treatment of thyroid nodules and thyroid cancer. Many of the test performed are in the
context of standard medical care that is offered to all patients with thyroid nodules or
thyroid cancer. Other tests are performed for research purposes. In addition, blood and
tissue samples will be taken for research and genetic studies.

Study summary:

The purpose of this study is to evaluate methods for preoperative diagnosis and therapy of
thyroid cancer and to screen patients for participation in other protocols. Study subjects
will include adults and children with thyroid nodules or cancer requiring diagnostic fine
needle aspiration biopsy, surgery, radioiodine scanning or therapy for persistent or
recurrent disease.
In this natural history protocol, the use of methods for follow-up of patients using
radiopharmaceutical tracers such as (131)I, (123)I, (99)mTc-Sestamibi, (111)Inpentetreotide
and 18-FDG PET will be evaluated. All radionuclides will be administered according to
standard clinical practice indications and published guidelines. The limitations and
significance of serum thyroglobulin (Tg) measurement for diagnosing tumor recurrence will be
assessed. The study will permit a continued evaluation of the risk/benefit ratio of already
established methods of administering (131)I therapy including the impact of pre-treatment
dosimetric calculations and administration of lithium (a well established, yet not widely
used, adjuvant to (131)I treatment), especially in selected cases of thyroid cancer in which
high-dose (greater than 150mCi) (131)I therapy is clinically indicated.
Under this protocol, samples of FNAB, benign nodules and cancer tissue specimens, blood
samples for research studies will be collected to assess new immunohistochemical and
molecular markers, and other techniques to characterize tumors for correlation with
diagnosis, response to therapy and prognosis. Blood and urine specimens will be collected for
future clinical and research studies in both the hypothyroid and euthyroid state. Coded
clinical data will be entered in the National Thyroid Cancer Registry in selected patients.

Criteria:

- INCLUSION CRITERIA:
Adults and children with known or suspected thyroid neoplasm will be considered for
participation.
1. Patients with thyroid nodules requiring evaluation and possible biopsy
2. Patients with recent diagnosis of thyroid cancer requiring consultation and counseling
about therapeutic options
3. Patients with established thyroid cancer requiring specialized studies such as (131)I
dosimetry
4. Enrollment of high risk, non-iodine avid, inoperable thyroid cancer for standard
treatment of screening for eligibility for other specific thyroid cancer protocols.
EXCLUSION CRITERIA:
1. Serious underlying medical conditions that restrict diagnostic testing or therapy such
as renal failure, congestive cardiac failure or active coexisting non-thyroid carcinoma;